An unsuspecting win for reproductive freedom was just made official by the US Food and Drug Administration (FDA). On July 13, the FDA approved the over-the-counter sale of Opill, the first nonprescription birth-control pill in the United States.
“Today’s approval is a groundbreaking expansion for women’s health in the US, and a significant milestone towards addressing a key unmet need for contraceptive access,” Frederique Welgryn, global vice president for women’s health at Perrigo, the parent company of HRA Pharma (manufacturer for Opill), said in a statement.
Opill, the contraceptive that’s been approved for OTC access, was originally approved for prescription use in the US in 1973, though it hasn’t been marketed in the country for over a decade, according to the Washington Post. Opill is a progestin-only pill (aka mini pill), one of two types of oral birth control available, and which are differentiated by the hormones they contain. The other type is a combination pill, which contains both estrogen and progestin and is more popular in the US, but also more closely associated with blood clots (though the risk is still very low). People who are already at risk for or who have a history of blood clots are not advised to take combination pills, per the Centers for Disease Control and Prevention, so progestin-only pills are typically offered as an alternative. People who suffer from migraine headaches or who are currently breastfeeding may also be prescribed the mini pill instead of a combination pill, according to the National Library of Medicine.
With the latest FDA approval, people will be able to purchase a daily progestin-only oral contraceptive, Opill, without a prescription at drug stores, convenience stores, and grocery stores, as well as online, according to a statement released by the FDA.
“When used as directed, daily oral contraception is safe and is expected to be more effective than currently available nonprescription contraceptive methods [such as condoms, spermicide, etc.] in preventing unintended pregnancy,” Dr. Patrizia Cavazzoni, the director of the FDA’s Center for Drug Evaluation and Research, said in the FDA statement.
While OTC birth control sounds like a straightforward way to improve contraceptive access, there is some concern about a potential price increase. The Affordable Care Act requires health insurance providers to cover prescription birth control, a benefit that would not apply to over-the-counter contraceptives. To address this issue, Welgryn said “Perrigo is committed to making Opill, which is now the most effective method available OTC at preventing pregnancy, accessible and affordable to women and people of all ages.”
The suggested retail price is expected to be announced in the coming months. And Opill will reportedly be made available over-the-counter in stores by the end of March 2024, per CNN.
— Additional reporting by Alexis Jones